Orange Book product · Generic (ANDA)
CLADRIBINE
CLADRIBINE
At a glance
Nov 25, 2019
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 25, 2019
6 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
CLADRIBINE
Strength
1MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 210856
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CLADRIBINE
- 2019MAVENCLADBrand (NDA)
NDA 022561 · EMD SERONO INC
- 1993LEUSTATINBrand (NDA)
NDA 020229 · JANSSEN PHARMS
- 2026CLADRIBINEGeneric (ANDA)
ANDA 215547 · HOPEWELL PHARMA
- 2025CLADRIBINEGeneric (ANDA)
ANDA 218425 · APOTEX
- 2011CLADRIBINEGeneric (ANDA)
ANDA 200510 · PHARMOBEDIENT
- 2004CLADRIBINEGeneric (ANDA)
ANDA 076571 · FRESENIUS KABI USA
- 2000CLADRIBINEGeneric (ANDA)
ANDA 075405 · HIKMA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
